Surgical package



SURGICAL PACKAGE Filed July 5. 1968 3 Sheets-Sheet 1 INVENTOR Job NJ M1754 ATTORNEY March 3, 1970 J. J. KUSTER SURGICAL PACKAGE 3 Sheets-Sheet 2 Filed July 5, 1968 INVENTOR \/omv J. Aasn-P BY M ATTORNEY March 3, 1970 J. J. KUSTER v SURGICAL PACKAGE s Sheets-Shee t :5

Filed July 5, 1968 INVENTOR 73 1/. 44/5775? United States Patent 3,498,448 SURGICAL PACKAGE John J. Kuster, Kendall Park, N.J., assignor to Johnson & Johnson, a corporation of New Jersey Continuation-impart of application Ser. No. 621,578, Mar. 8, 1967. This application July 3, 1968, Ser.

Int. Cl. A61b 19/02 US. Cl. 206-632 6 Claims ABSTRACT OF THE DISCLOSURE Sterile packages are disclosed in which the outer wrapper has an integral tear strip which when removed provides an opening for access to the sterile product, the tear strip being so positioned and of such a shape that when it is removed, the outward facing surfaces of the outer wrapper adjacent the access opening are sterile surfaces.

This application is a continuation-in-part of my copending application Ser. No. 621,578, filed Mar. 8, 1967, now abandoned.

Articles and devices which are used in surgical, obstetrical, and many other medical procedures must be enclosed in a bacteria impervious sterilized package so that they remain free of bacteria until they are used. Surgical packages are therefore conventionally made of materials which are generally impervious to bacteria with at least a portion being pervious to gases so that the package may be sterilized with the article as an integral part of the same.

These packages must also be designed so that they may be opened rapidly without affecting the sterility of the article contained therein and so that the articles may be removed from the package according to approved sterile techniques.

Various means are provided for opening sterile surgical packages. When the package is in the form of a bag or the like, one of the most common opening means is a colored marker at an end or corner of the package indicating an area which may be torn or otherwise severed from the package to provide direct access to the article without affecting its sterility. Once the walls of the package have thus been severed, the sterile article is removed with the aid of forceps or the like.

A second means commonly provided to facilitate the opening of sterile surgical packages is a tear string inserted within a portion of the package wall and projecting outward from the same through a small hole which is carefully sealed around the string to prevent bacteria from entering the package. To open the package, the string is pulled generally parallel to the surface of the package wall to rupture the package wall. Again the sterile article is removed through the article access area defined by the severed edges of the package wall.

A third technique used to facilitate the opening of surgical packages is to form a portion of the package by sealing two materials together which, while they form a strong seal, are readily peelable. When the walls of the package are peeled apart and at least one wall bent back, access to the sterile article is provided and the same can be removed from the package.

No matter which of these techniques is used, when the package walls are severed to provide an article access opening, the outward facing surface areas of the package lying immediately adjacent the article access opening are nonsterile surfaces. Thus, in removing the sterile article through the opening, care must be taken so that the article does not touch the edges of the article accessopening.

3,498,448 Patented Mar. 3, 1970 If the sterile article touches these edge surfaces, the article is considered contaminated and must be discarded.

It has now been found that surprising and significant advantages may be obtained and the above outlined problems eliminated by incorporating integral tear strips particularly of the general type disclosed, for example, in US. Patent 2,608, 341 to Eckman and US, Patent 2,626,- 096 to Hickin in the package in a manner so that when the strip is removed to provide an article access opening, the outward facing package surfaces adjacent the article access opening are sterile surfaces.

One embodiment of the present invention is a sterile surgical package having a bacteria impervious paperboard panel and an integral removable tear strip in the paperboard panel, the tear strip including an integral tab and being set off by a pair of spaced, preferably parallel, weakened areas or score lines cut into the exterior surface of the paperboard panel, at least one weakened area in the form of a score line preferably generally parallel with and between the aforesaid pair of weakened areas being cut into the interior surface of the paperboard portion of the package, the score lines cut into the exterior surface of the paperboard panel and the score line out into the interior surface of the paperboard panel cooperating to form a cleavage plane within the thickness of the panel between each exterior score line and an interior score line. When the paperboard panel is severed by the removal of the integral tear strip, the portion of the paperboard panel lying between the exterior score lines and an interior score line or lines delamina-tes along the cleavage plane to thus form an exterior facing sterile surface bordered outwardly by the exterior score lines and inwardly by an interior score line, Thus when an article is removed from the package through the article access opening defined by the ruptured panel Walls, the article is not contaminated if it touches the exterior surfaces surrounding the article access opening since the same are sterile.

The general use of integral tear strips with a cooperating tab in packages is a well-known technique as shown, for example, by US. Patent 2,608,341 to Eckman and US. Patent 2,626,096 to Hickin. However, such tear strips have not been utilized in surgical packages. In order to form an integral removable tear strip in a package, it is necessary to provide an extending tab at one end of the strip as illustrated in FIG. 1 of the referred-to patent to Eckman. However, it is quite important that a surgical package be completely sealed and therefore it is necessary to seal the extending tab of the integral tear strip to some underlying package panel. In the case of a package of the type described in the patent to Eckman, which is not adapted to surgical uses, it is not necessary to seal the tab to the underlying package panel, and therefore the same may be easily removed in the usual fashion. However, when the under surface of the tab is sealed to the underlying panel and it is attempted to remove the tear strip by using the tab, the adhesive or other bond between the tab and the underlying panel is stronger than the bond between various layers of the easily delaminatable paperboard panel, and thus the portion of the paperboard panel within the tear strip tends to delaminate along some intermediate plane usually near the inner surface. Therefore due to this delamination within the tear strip or the underlying surface of the panel, it may be impossible to remove the tear strip to open the package. The tear strip may also internally delaminate haphazardly in such a fashion that it is severed somewhere along its length. This type of tear strip failure is quite unsatisfactory in a sterile surgical package since the same must be easily and assuredly openable at the critical moment when the article contained therein is required in the operating room without endangering the sterility of the product.

In packages not intended for medical use where a bacteria impervious package with an integral tear strip is required, the same has usually been made of metal or some other substance resistant to delamination and the tab portion soldered or welded to the underlying structure. However, packages made from metal or the like are not usually satisfactory for medical use because of the impossibility of passing sterilizing gases therethrough, more difiicult sterilizing techniques being required.

In the preferred embodiments of packages of this invention, this problem is eliminated by a score line cut into the inner surface of the tear strip or into the underlying surface inward of the major portion of the seal and transversely of the tear strip. Thus, the transverse score line will terminate any delamination that occurs.

The invention may be more clearly understood by reference to the appended drawings which are described in detail below:

FIG. 1 is a top plan view in perspective of one type of the surgical packages of this invention;

FIG. 2 is a partial cross section of the package of FIG. 1 taken along line 2-2;

FIG. 3 is a bottom plan view of the surgical package illustrated in FIG. 1;

FIG. 4 is an enlarged cross section of the bottom panel of the package as illustrated in FIG. 3 taken along line 4-4;

FIG. 5 is an enlarged bottom plan view in perspective of the tear strip portion of the package as shown in FIG. 3 and additionally indicates the first step in the opening of the package and the manner in which the paperboard panel delaminates when the tear strip is removed;

FIG. 6 is a cross section of the removed portion of the tear strip as shown in FIG. 5 and taken along line 66;

FIG. 7 is a cross section of the bottom paperboard panel as shown in FIG. 5 after the tear strip is removed and taken along lines 77;

FIG. 8 is a view in perspective of the package after the same has been opened;

FIG. 9 is a top view in perspective of a preferred embodiment of the surgical package of the type illustrated in FIGS. 1-8;

FIG. 10 is a top view in perspective of the bottom paperboard panel of the package illustrated in FIG. 9;

FIG. 11 is an enlarged plan view of a portion of the tear strip area of the paperboard panel as illustrated in FIG. 10;

FIG. 12 illustrates the first step in the opening of the package of FIG. 9;

FIG. 13 is an enlarged plan view of the open portion of the package illustrated in FIG. 12;

FIG. 14 is a side view of the package of FIG. 9 after the same has been opened;

'FIG. 15 is a plan view of a paperboard panel blank illustrating another embodiment of the present invention;

FIG. 16 is a fragmentary perspective view showing the blank of FIG. 15 folded into a generally rectangular package;

FIG. 17 is a fragmentary plan view showing another embodiment of the invention; and

FIG. 18 is a fragmentary plan view showing still another embodiment of the invention.

Referring now to the package illustrated in FIGS. 1-11, and particularly to FIGS. 1-4, the surgical package 20 consists of a 16 mil thick 5" x 12" bacteria impervious but air pervious paperboard bottom panel 3, a sterile surgical sheet 1, and a 3 mil thick polyethylene film blister 2, overlying and molded around the sterile sheet 1 and heat sealed to the paperboard panel 3 in a onehalf inch wide area 21 around the entire perimeter 0f the film blister 2, outward of the sterile sheet 1. Two parallel score lines 6 and 7, one inch apart are cut into the paperboard panel 3 from the exterior surface of the same, approximately halfway through the paperboard panel 3 and extending across the entire width of the panel. Two parallel score lines 4 and 5, one-half inch apart and centrally located between score lines 6 and 7 are cut into the paperboard panel 3 from the interior surface of the same halfway through the panel and extend across the entire width of the same to complete the definition of the tear strip 8. The blister 2 terminates short of the edge 23 of the paperboard panel 3 to provide' tabs 24 in area 22 at the ends of the tear strip.

Referring now to FIGS. 5-8, when it is time to open the-package, the doctor or nurse may grasp the tab 24 at the end of the tear strip lying outward of the area 21 in vvhich the blister film 2 is sealed to the paperboard panel 3 and pulls the tab backward as illustrated. The portion of the paperboard panel lying between score lines 6 and 7 delaminates along the weakest interior plane, namely, along cleavage plane P which is essentially intersected by both sets of score lines 6 and 7 and 4 and 5, as shown most clearly in FIGS. 6 and 7. Once the tear striphas been removed, interior, and therefore sterile, portions 9 and 10 of the bacteria impervious paperboard panel become exteriorly facing surfaces adjacent edges 11 and 12 of the article access opening 25. Thus, as illustrated in FIG. 8, when the film blister 2 is folded back, the sterile sheet may be removed without concern about the sheet touching edges 11 and 12 or outward facing surfaces 9 and 10 lying adjacent the article access opening.

When it is attempted to open the package illustrated in FIGS. 1-11 the thermoplastic bond 21 between the blister film 2 and paperboard panel 3 in the area of the tear strip 8 is substantially stronger than the internal cohesive strength of the paperboard sheet 3. Thus, the paper-board panel often begins to delaminate Within the tear strip along some plane P shown in FIG. 4, near the bonded surface of the same. If this delamination continues, after the tear strip is removed, a thin band of paperboard 26, shown clearly in FIG. 7, having a width approximately equal to the distance between interior score lines 4 and 5, will remain in the article access area sealed at each end to the blister film. If instead of continuing on a given plane, the delamination proceeds angularly through the longitudinal cross section of the tear strip, the tear strip may break.

Referring now to FIGS. 11-14, the package illustrated therein is a preferred embodiment of the type of package illustrated in FIGS. 1-8 and similar elements are generally indicated by the same reference numbers as referred to in the description of the earlier package followed by the letter a.

In the preferred embodiment of the package shown in FIGS. 11-14, a score line 27, disposed transversely of the tear strip 8a, inwardly of the area 21a in which the blister 2a is sealed to the paperboard panel 3a and extending between longitudinal interior score lines 4aand 5a is cut into the inner surface of the paperboard panel 3a to about the middle of the panel thickness. Thus, if the tear strip begins to delaminate between the inner score lines 4a and 5a in the area 21a of its seal to the blister film and near the surface which is sealed to the film, the transverse score line will terminate the delamination.

In the packages of this invention, the so-called score lines need not be in the form of continuous grooves cut into the paperboard panel but may consist of any series of weakened areas along which the panel can be readily and regularly split. The score lines also need not be straight lines but can have any configuration, and cooperating score lines need not be parallel though they must be nonintersecting. Various types of score lines are well known in the art and will not be further described here.

As previously stated, for the proper functioning of the packages of this invention, a pair of exterior score lines are required, and in packages of the type illustrated in FIGS. 1-14 at least one inner score line is necessary. This inner scoring may, for example, either consist of a pair of cooperating score lines such as disclosed in US. Patent 2,608,341 to Eckman or a single cooperating score line also disclosed in that patent. In either case, outer score lines and any inner score lines should essentially intersect some common plane in the interior of the panel and must at least come close to doing so to form a cleavage plane. Thus the paperboard lying between the inner and outer score lines will split along one of these planes. It is particularly convenient if both the inner and outer score lines are cut to a depth equal to half the thickness of the panel. Thus when the tear strip is removed, the sterile edges will be thick enough to resist bending when the sterile article is brushed against the same, and the outer package surfaces which are not sterile will lie a substantial distance from the sterile edges 11 and 12. The score lines need not be continuous nor extend the entire length of the tear strip. For example, in the package of FIG. 11, the portion of the score lines 4a, 5a, 6a and 7a lying outward of cross score line 27 can be eliminated. In this case, the cross score line will serve to initiate proper tearing.

It has also been found that in order to initiate proper tearing or terminate undesirable delamination, the transverse score lines may be cut into either the inner surface of the tear strip or the panel surface underlying the tear strip. This is best illustrated in FIGS. 15-18 wherein the transverse score lines are shown in a variety of locations. The only crilical condition is that the transverse score lines be so positioned that they terminate any delamination that may occur either on the tear strip itself or on the surface underlying the tear strip. 1

Referring to FIGS. 15 and 16, a paperboard panel blank 50 is illustrated in a flat unfolded condition and a folded generally rectangular position, respectively. A pair of substantially parallel score lines 51 and 52 are cut into the surface of blank 50 and a second pair of substantially parallel score lines 53 and 54 are cut into the opposite side of blank 50 inwardly of score lines 51 and 52. These parallel score lines form a tear strip that is essentially identical to that previously described and also may be removed from the paperboard package in the manner previously described.

A transverse score line 55 is cut into the surface of the blank 50 near one end of the tear strip on one side of the blank and a second transverse score line 56 is cut into the opposite end of the tear strip on the opposite side of blank 50. Line 57 represents an adhesive strip that is adapted to secure the paperboard panel in an overlapped position as shown in FIG. 16.

Referring to FIG. 16, it may be seen that both transverse score lines 55 and 56 are at a location more remote from the free end of the tear strip than the adhesive line 57. Therefore, when the free end 58 of the tear strip is initially removed from the underlying paperboard panel, any delamination that may occur on either the underlying surface of the panel or the inner surface of the tear strip will be terminated by either transverse score line 55 or transverse score line 56, respectively. In either case, the undersidable delamination and the associated uneven tear ing of the tear strip will be eliminated and the sterility of the package will be maintained.

Referring to FIG. 17, a fragmentary portion of a paperboard panel blank 60 is illustrated wherein a pair of substantially transverse score lines 61 and 62 are cut into the surface of the blank remote from the end 63 of the tear strip which is to be initially removed from the package. When this blank is folded into a generally rectangular surgical package, as shown in FIG. 16, the portion adjacent the end of the tear strip 63 will be secured in position over adhesive strip 64 and transverse score lines 61 and 62. When end 63 of the tear strip is removed from the package, the strong bond created by adhesive 64 will cause the portion 65 of the underlying surface that is located between score lines 61 and 62 to firmly adhere to the inner surface of the tear strip and be removed from the underlying panel construction. The delamination is initiated by score line 62 and terminated by score line 61. This may be referred to as controlled delamination since it accomplishes the desired result of preventing uneven delamination of the inner surface of the tear strip.

In the embodiment of the invention shown in FIG. 18, the double transverse score lines 71 and 72 are cut into the inner surface of the free end 73 of the tear strip that is to be initially removed from the package. When the paperboard panel blank 70 is folded into a generally rectangular sleeve construction and secured by adhesive 74, the transverse score lines 71 and 72 will be located on opposite sides of the adhesive and the subsequent removal of end 73 of the tear strip from the paperboard panel will cause removal of the area 75 located between the score lines in the. manner hereinabove described in the description of the FIG. 17 embodiment.

It will be appreciated that in all of the embodiments illustrated in FIGS. 15-18, the ends of the package remote from the tear strip construction must be sealed to provide a completely sterile package.

If a cross score line is used in the packages of this invention, it suitably has a depth which is also about equal to one-half the thickness of the panel and should at least penetrate into the panel /s or A of its thickness. While the cross score line is preferably perpendicular to longitudinal direction of the tear strip, this need not be the case. The cross score line may take many shapes including that of an apex, a semicircle, or the like. All of the score lines may be cut by means and methods well known in the art.

The paperboard panels themselves are of the type conventionally used in sterile surgical packages, namely, those that have a density which is such as to make the panel pervious to gases but impervious to airborne bacteria. Generally any paperboard sheet having a porosity of from 50 to 200 seconds per cc. of air per square inch measured by TAPPI Standard T 460-M49 will be satisfactory.

Although specific embodiments of the invention have been presented, they have only been presented to better describe the inventive concept and should not be construed to limit the invention.

What is claimed is:

1. A sterile surgical package comprising an outer protective wrapper enclosing a sterile article, at least a portion of the outer wrapper comprising a bacteria impervious paperboard panel, said package having an article access opening defined by an integral removable tear strip which is in turn defined at least in part by a series of weakened areas in said paperboard panel, said tear strip being defined by a pair of spaced score lines cut into the exterior surface of the paperboard panel and extending partially into the paperboard panel, and by at least one score line cut into the interior surfaceof the paperboard panel and lying between the exterior score lines, each outer score line cooperating with an inner score line to form a cleavage plane within the thickness of the paperboard panel, whereby when the integral tear strip is removed the paperboard panel will delaminate along the cleavage plane between said exterior score lines and said interior score lines so that the innermost exterior facing adjacent said article access area will be sterile surfaces, at least a portion of the inner surface of the paperboard panel lying within the tear strip being bonded to an underlying surface, and an additional score line in the form of a groove being cut into at least one of the inner surfaces of the tear strip of the paperboard panel and the underlying surface transversely of the tear strip and inward of the major portion of said bond, whereby any delamination of said inner or underlying surfaces that occurs in the bonded area incident to the removal of the tear strip will be terminated by said transverse score line.

2. The package of claim 1 further comprising at least a second transverse score line formed in the inner surface of said tear strip outward of said bond.

3. The package of claim 1 wherein said score line is formed in said underlying surface at a location more remote from the free end of said tear strip than said bond.

4. The package of claim 3 further comprising at least a second transverse score line formed in said underlying surface at a location nearer said free end of said tear strip than said bond.

5. The sterile surgical package of claim 1 comprising a generally rectangular sleeve, said sleeve being formed of a paperboard blank folded to overlap itself and adhesively sealed to itself in at least a portion of the area of overlap, said integral tear strip extending around at least three sides of the sleeve and through the area in wh ch the paperboard panel is bonded to itself, said transverse score line lying inward of the major portion of the bonded area.

6. The sterile surgical package of claim 1 comprising a paperboard panel, a sterile article positioned on the paperboard panel, and a plastic blister film overlying the sterile article and sealed to the paperboard panel around its entire perimeter, outward of the sterile article, said integral tear strip in said paperboard panel extending across the same and through said sealed area, said transverse score line lying inward of the seal between the plastic blister film and said paperboard panel.

References Cited MARTHA L. RICE, Primary Examiner US. Cl. X.R. 

